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Intrauterine Instillation of Tranexamic Acid in Hysteroscopic Myomectomy

The Effect of Intrauterine Instillation of Tranexamic Acid on Postoperative Hemoglobin in Hysteroscopic Myomectomy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110530006640N8
Enrollment
70
Registered
2021-03-07
Start date
2021-03-21
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Submucous leiomyoma of uterus. Submucous leiomyoma of uterus

Interventions

Intervention 1: Intervention group: In the intervention group, tranexamic acid ampoule with a dose of 0.5 g per 1000 cc of normal saline distending medium will be used (considering that the injection

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients with one submucosal myoma Myoma should be completely in the endometrial cavity or extending less than 50% into the myometrium (type 0 and 1, based on FIGO's classification) Myoma size less than 4 cm in the largest diameter confirmed by accurate transvaginal ultrasound Candidates for hysteroscopy and myomectomy

Exclusion criteria

Exclusion criteria: Pelvic infections History of uterine or cervical cancer; Hematological, cardiovascular, thromboembolic, hepatic, and renal disorders; or Thromboembolic events Taking anticoagulant agents Uterine septum, or uterine disorders

Design outcomes

Primary

MeasureTime frame
Hemoglobin Level. Timepoint: Once before surgery and once 24 hours after surgery. Method of measurement: Blood Test.

Secondary

MeasureTime frame
Amount of bleeding. Timepoint: Immediately after surgery. Method of measurement: Checklist.;Surgeon's field of view. Timepoint: Immediately after surgery. Method of measurement: Checklist.;Duration of surgery. Timepoint: Immediately after surgery. Method of measurement: Checklist.;The amount of medium used. Timepoint: Immediately after surgery. Method of measurement: Checklist.;Complications during surgery (Uterine perforation). Timepoint: Immediately after surgery. Method of measurement: Checklist.;Completing myomectomy. Timepoint: Immediately after surgery. Method of measurement: Checklist.;Rare side effects of Tranexamic Acid (Pulmonary embolism). Timepoint: Immediately after surgery. Method of measurement: Checklist.;Rare side effects of Tranexamic Acid (Headache). Timepoint: Immediately after surgery. Method of measurement: Checklist.;Rare side effects of Tranexamic Acid (abdominal cramps). Timepoint: Immediately after surgery. Method of measurement: Checklist.;Rare side effects of Tranexamic Acid (Weakness). Timepoint: Immediately after surgery. Method of measurement: Checklist.;Rare side effects of Tranexamic Acid (Back Pain). Timepoint: Immediately after surgery. Method of measurement: Checklist.;Rare side effects of Tranexamic Acid (Cramps and Muscle Spasms). Timepoint: Immediately after surgery. Method of measurement: Checklist.;Complications during surgery (Thermal injury). Timepoint: Immediately after surgery. Method of measurement: Checklist.;Complications during surgery (Overload of distention media). Timepoint: Immediately after surgery. Method of measurement: Checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Venus Chegini

Tehran University of Medical Sciences

venus_chegini@yahoo.com+98 21 7771 9922

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026